Advice for healthcare professionals:
- rapid reduction in hepatitis C viral load during direct-acting antiviral therapy for hepatitis C may lead to improvements in glucose metabolism in patients with diabetes, potentially resulting in symptomatic hypoglycaemia if diabetic treatment is continued at the same dose
- be vigilant for changes in glucose tolerance and advise patients of the risk of hypoglycaemia during direct-acting antiviral therapy, particularly within the first 3 months when the viral load is being reduced, and modify diabetic medication or doses when necessary
- physicians who initiate direct-acting antiviral therapy in patients with diabetes should inform the healthcare professional in charge of the diabetic care of the patient
- report any suspected adverse drug reactions associated with direct-acting antiviral therapies to the Yellow Card Scheme without delay
Evidence for hypoglycaemia during direct-acting antiviral therapy
Studies show that some patients with diabetes initiating direct-acting antiviral therapy for hepatitis C have experienced hypoglycaemia. The studies indicate that achieving sustained virological response (SVR) is associated with improvements in glycaemic control, compared to patients who relapse or are non-responders. Many studies recorded these changes in glycaemic control in the first 3 months of treatment. Some studies reported the need to adjust patient’s diabetic medication following changes in glucose metabolism, with up to 30% of patients requiring adjustments to their treatment.
An EU review confirmed the risk of hypoglycaemia in patients with diabetes who had been initiated on direct-acting antivirals for chronic hepatitis C. Information on the risk is being added to the Summary of Product Characteristics and Patient Information Leaflet for these medicines.
Patients with diabetes should be closely monitored for changes in glucose levels, particularly in the first 3 months of treatment, and adjustments to their diabetic medication or doses made where necessary.
Direct-acting antivirals for chronic hepatitis C infection include: daclatasvir (Daklinza▼); sofosbuvir/velpatasvir (Epclusa▼); ledipasvir/sofosbuvir (Harvoni▼); sofosbuvir (Sovaldi▼); sofosbuvir/velpatasvir/voxilaprevir (Vosevi▼); dasabuvir (Exviera▼); ombitasvir/paritaprevir/ritonavir (Viekirax▼); glecaprevir/pibrentasvir (Maviret▼); and elbasvir/grazoprevir (Zepatier▼).
Report any suspected adverse drug reactions
Any suspected adverse drug reactions to direct-acting antivirals should be reported to us on a Yellow Card. Healthcare professionals, patients, and caregivers can report suspected side effects via the Yellow Card website or via the Yellow Card app. Download the app today via iTunes Yellow Card for iOS devices or via PlayStore Yellow Card for Android devices.
You can also use the app to access the latest safety information from MHRA about medicines and medical devices on the Newsfeed. Search for medicines to see details of Yellow Card reports others have made. Medicines of interest can also be added to a Watch List to receive news and alerts about new side effects and safety advice as it emerges.
Pharmacovigilance Risk Assessment Committee recommendations on signals adopted at the 1-4 October 2018 meeting.
Article citation: Drug Safety Update volume 12, issue 5: December 2018: 4.
Published 18 December 2018